Prescription medicine
Somatrogon Brand names: Ngenla
Somatrogon (Ngenla) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the somatrogon FDA label on DailyMed (effective August 14, 2026); every somatrogon label on DailyMed.
Highlights of the record
FDA label of August 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
Forms and strengths
- 24 mg/1.2ml
- 60 mg/1.2ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,211 through July 30, 2026
What is somatrogon used for?
From the label: indications and usageNGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
FDA pharmacologic class: Recombinant Human Growth Hormone.
Source: FDA drug label (Ngenla), Pfizer Laboratories Div Pfizer Inc, effective August 14, 2026 (SPL set 06dce529-b741-4a1b-8842-3ad77be6e308), via openFDA; the full label on DailyMed
Is there a generic for somatrogon (Ngenla)?
No generic somatrogon is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the somatrogon label say about other medicines?
The somatrogon label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cortisone | drug interactions | Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone inhibits 11βHSD-1. … maintenance or stress doses following initiation of NGENLA [see ]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites … |
| Prednisone | drug interactions | Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone inhibits 11βHSD-1. … doses following initiation of NGENLA [see ]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the … |
| Somatropin | contraindications | Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1) ]. |
Source: FDA drug label (Ngenla), Pfizer Laboratories Div Pfizer Inc, effective August 14, 2026 (SPL set 06dce529-b741-4a1b-8842-3ad77be6e308), via openFDA; the full label on DailyMed
What do FAERS reports show for somatrogon?
The FDA Adverse Event Reporting System holds 1,211 reports that list somatrogon among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 47 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other recombinant human growth hormones
- the pharmacologic class, with prices and generics
- Somatrogon side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other